The change of blood donation modes from paid and mobilized unpaid to voluntary unpaid blood donation
In 1998, the Blood Donation Law became a symbol of the VNRBD system in China. VNRBD, family replacement/mutual blood donation (FRMBD), and employer-organized blood donation were the three types of blood donation programs permitted by the Blood Donation Law (see Figure 1).
Employer-organized blood donation is an interim policy from paid blood donation to voluntary unpaid blood donation. In 2005, employer-organized blood donation, workers’ blood donation as pre-arranged by the employer, and local blood stations, a semi-obligatory and mobilized unpaid mode, were banned by the Chinese government [19, 20]. The reason for the ban was that those who donated blood, as required by their employer, were exposed to undue pressure and had higher rates of infectious disease markers compared to volunteer donors [21, 22, 23, 24]. In fact, the cancellation of employer-organized blood donation meant that China implemented a voluntary unpaid donation system nationwide, thereby eliminating paid donation by 2005. Of course, group voluntary blood donation, as a mode of VNRBD, is allowed in China, accounting for a large percentage of blood donation. Group blood donation has the advantage of being arranged in advance, making up for seasonal shortages in street blood collection and emergency mobilization [25].
There are three identified types of blood donors in the WHO Blood Safety and Availability Report: voluntary unpaid, family or replacement, and paid [12]. FRMBD is concerned with patients’ family members, relatives, and friends – the unit to which he or she belongs in the community – under blood donation for mutual aid, thereby ensuring the supply of blood for citizens’ clinical first-aid treatment [26]. FRMBD has been widely used for more than 20 years in China. Since 2009, the government of China has been giving increased attention to the proportion of FRMBD in blood collection. According to the NHC, the policy of FRMBD was canceled in 2018 across most regions, to improve blood quality and safety [27].
Roles of the government, blood centers, and medical institutions in the management of blood collection and transfusion
Blood must be used for official clinical activities. Any form of blood trade has been banned by the Chinese government to assure the quality and safety of blood collection, which were listed in accordance with blood-related laws and regulations (see Table 1). (From 1996 to 2013, China’s National Health Administration agency was The Ministry of Health, and it was revoked and replaced by The National Health and Family Planning Commission from 2013 to 2018. Since March 2018, it has been replaced by the NHC). Even the importation and exportation of blood was forbidden in 2017 [28]. To encourage donation, the government provides voluntary blood donors with a holiday, a nutrition allowance, and priority access to blood transfusion during emergencies [29].
Table 1
The Outline of Laws and regulations related to Blood Donation and Safety in China
Type
|
Act
|
Legal sources
|
Implementation Years
|
Legislature
|
Main points
|
Specific Legislations
|
Regulations on Blood Collection and Supply Institution and Blood Administration
|
Regulation
|
1993
(1998 Expired)
|
The Ministry of Healtha
|
Permission of The Blood Centre
Blood Donor Registration
Promotion of VNBD
|
Detailed Rules for the National Verification of External Immunodiagnostic Reagent for Blood Use
|
Regulation
|
1994
|
The Ministry of Health
|
Test of HIV, HBV, HCV, Syphilis
|
Regulations on Administration of Blood Products
|
Regulation
|
1996(2016 Revision)
|
Instrumentalities of the State Council
|
Blood Product Administration
|
Blood Donation Law
|
Law
|
1998
|
Standing Committee of the National People's Congress
|
VNBD System; Blood Only for Clinical Use
|
Measures for the Administration of Blood Centres (for Trial Implementation)
|
Regulation
|
1998
(2006 Expired)
|
The Ministry of Health
|
Blood Centre Administration
|
regulations on Clinical Use of Blood in Medical Institutions (for Trial Implementation)
|
Regulation
|
1999
(2012 Expired)
|
The Ministry of Health
|
Clinical Blood Use
|
Technical Standards for the Clinical Blood Transfusion
|
Regulation
|
2000
|
The Ministry of Health
|
Corss-Match Test
Blood Transfusion Record
|
Measures for the Administration of Blood Centres
|
Regulation
|
2006 (2009,2016༌2017 Amendment)
|
The National Health and Family Planning Commissiona
|
Classification and Management Of Blood Centre
Blood Specimen Restoration
2017 Cancellation of Blood Imports and Exports
|
Provisions on Clinical Use of Blood in Medical Institution
|
Regulation
|
2012
|
The National Health and Family Planning Commission
|
Clinical Blood Use
Emergency Blood Use
|
Technical Operating Procedures for Blood Centres (2019 Edition)
|
Regulation
|
2019 Edition
(2005, 2012, 2015 Edition Expired)
|
The National Health Commissiona
|
NAT in clinical use
|
Other Relative Legislations
|
Regulation on the Handling of Medical Accidents
|
Regulation
|
2002
|
Instrumentalities of the State Council
|
Fault Compensation Liability
|
Tort Law
|
Law
|
2010
|
Standing Committee of the National People's Congress
|
Principle of No-Fault Liability in Blood Transfusion Tort
|
Pharmaceutical Administration Law
|
Law
|
1984
(2001, 2002, 2004, 2016, 2017, 2019 Revision)
(2013 Amendment)
|
Standing Committee of the National People's Congress
|
Blood Products Blood Products Cannot Be Commissioned Production and Sell Online
|
Prevention and Treatment Of Infectious Diseases Law
|
Law
|
1989
(2004 Revision)
(2013 Amendment)
|
Standing Committee of the National People's Congress
|
Ensure the Quality Of Blood And Blood Products To
Prevent Transfusion-Transmitted Diseases
|
Local
Legislation
|
Regulations on Voluntary Blood Donation By Citizens Of Beijing
|
Regulation
|
1992
(1998 Expired)
|
Beijing’s Standing Committee of the National People's Congress
|
Promotion of voluntary blood donors
|
Regulations on Shenzhen Special Economic Zone on Citizen's Gratis of Blood Donation and Blood Management
|
Regulation
|
1995
(2015 Expired)
|
Shenzhen’s Standing Committee of the National People's Congress
|
Reimbursement of VNBD
|
Regulations of Beijing Municipality on Mobilizing and Arranging for Citizens to Donate Blood
|
Regulation
|
1998
(2006 Expired)
|
Beijing’s Standing Committee of the National People's Congress
|
VNBD system
|
Rules of Guangzhou Municipality on Donation of Blood
|
Rules
|
2004
(2015 Amendment)
|
Guangzhou Municipal People's Government
|
Mutual Blood Donation
|
Regulations of Nanning Municipality on Blood Donation
|
Regulation
|
2004
(2012 Revision)
|
Nanning’s Standing Committee of the National People's Congress
|
VNBD system
|
Measures of Beijing Municipality for Administration of Blood Donation
|
Rules
|
2009
|
Beijing Municipal People's Government
|
VNBD publicity and the service
|
Regulations on Shenzhen Special Economic Zone Blood Donation
|
Regulation
|
2015
(2019 Amendment)
|
Shenzhen’s Standing Committee of the National People's Congress
|
VNBD incentives
|
Measures of Nanning for rewarding blood donation
|
Rules
|
2017
|
Standing Committee of Nanning Municipal People's Government
|
VNBD incentives and rewarding
|
aFrom 1996 to 2013 the national health administration department of China is The Ministry of Health, and it was revoked and replaced by The National Health and Family Planning Commission from 2013 to 2018. Since March 2018, it was replaced by The National Health Commission. |
Blood centers serve as the main institution in the collection of blood. From 1993 to 1998, the establishment of blood centers has been consistently approved by the Red Cross Society in China [30]. After the Measures for Blood Center Administration (for Trial Implementation) were implemented in 1998, the blood center was defined as a nonprofit, public welfare organization, and its establishment was thereafter managed by the health administration department of the provincial government [31]. Blood centers provide the necessary health examination and blood collection service for voluntary unpaid blood donors, maintain blood supply for clinical use, and are responsible for storage and transportation [32]. Blood collected from donors is tested to avoid quality problems [33].
The medical institution is the only legal institution for the clinical use of blood. The Blood Donation Law stipulates that all blood and blood products must be tested before transfusion in medical institutions to ensure safety [34]. Other regulations and technical standards regarding blood centers and medical institutions are listed in Table 1. These guidelines and regulations have the effect of strengthening the management of blood collection and enhancing the level of blood safety.
Significant increase in blood collection and supply
Before 1998, the recruitment of blood donor volunteers was a very challenging endeavor in China. Traditional Chinese medicine holds that the loss of even a small amount of blood was harmful to health; this was also why paid blood donation was common at the time [3].
Since the 1998 implementation of the Blood Donation Law, and encouragement of unpaid blood donation through laws and policies [35], the number of unpaid blood donors and the amount of blood collected in China have been continuously increasing for 20 years ( Figure 2). (Data on 1998, 2010, 2011, 2014, 2015, 2016, 2017, 2018 from the NHC. Data on 2012 and 2013 from the Global Database on Blood Safety). The steady increase in the number of unpaid blood donors and the amount of blood collected has ensured the safe supply of blood from the source [11].
The proportion of unpaid blood donation, which was only 8% in 1998, increased to 95.5% in 2005. After 2009, all clinical blood came from unpaid donation [36]. In response to the call of The Melbourne Declaration on 100% VNRBD and Blood Components, the Chinese government engaged in efforts to popularize VNRBD donors and joined the list of countries which reported almost 100% blood collection in 2011 [37].
Through the establishment of a multi-level alarm mechanism when blood is in short supply, and the deployment of resources in different blood centers, seasonal, regional, and partial blood donation problems have been solved to a great extent. In 2015, 1.19 million units of blood were allocated across the country, reaching 1.54 million in 2017 [38]. In 2018, a total of 1.84 million units of blood were allocated across the country, of which 1.585 million units (86.1%) were allocated between the cities in the same province and 255 thousand units (13.9%) were allocated between provinces. The policy of raising an alarm regarding the need for blood and deploying it effectively ensured clinical blood supply in need-intensive areas and for major public health events [11].
The rise and fall of FRMBD in VNRBD
Since 1998, according to Article 15 of the Blood Donation Law, patients’ family members, relatives, friends, and colleagues have been allowed to donate blood for mutual aid in emergency situations. FRMBD is a double-edged sword for blood donation. On the one hand, it can solve the shortage of blood. On the other hand, the risk of blood trade exists in mutual blood donation. The WHO has stressed that when mutual blood donation accounts for more than 5% of unpaid blood donation, there is a risk of illegal blood trade.
As a specific mode of donation, it was able to relieve the shortage in clinical blood in China. FRMBD accounted for 0.41% of the national blood collection in 2009 [39]. In 2015, it increased to 4.2% (see Figure 3) nationwide. In some provinces, it was significantly higher, such as in Hainan (35.6%), Guangxi (25.9%), Xinjiang (11.7%), Gansu (9.5%), and Guangdong (9.3%) [40]. In Xinning City of Guangxi Province, it was up to more than 50% [41], while it was 21% in Beijing in 2017 [42].
However, the rules for mutual blood donation in the Blood Donation Law are too wide in scope for FRMBD and leave room for criminals to sell blood illegally, thereby increasing people’s distrust regarding voluntary blood donation and lowering the quality and safety of donated blood [43]. Private transactions between donors and recipients cannot be supervised by medical institutions or blood centers.
To ensure the quality and safety of blood collection, the NHC issued a government order to cancel FRMBD nationwide, except for some remote areas, by March 2018 [27]. At present, most areas have completely stopped FRMBD. There is no doubt that the cancellation of blood donation imposes a burden on the clinical blood shortage in hospitals [44]. In response to this, VNRBD should be promoted and inter-provincial transfers of blood should be properly allocated to maintain the balance of blood supply and demand.
Development of blood safety in China
Blood safety, to a large extent, depends on whether the blood source is safe. Ensuring the safety of blood collected is the first step in the process. It took the Chinese government four years to establish and strictly implement the testing procedures, and they have been continuously improving it over the past two decades.
China’s commercial plasma selling emerged in the early 1980s [45]. Since 1993, blood donors have been required to be tested for HIV, hepatitis B, hepatitis C, and syphilis in order to reduce infections through transfusion according to the Health Examination Standards for Blood Donors [32]. However, these regulations were not fully implemented, and HIV-positive individuals could enter the blood plasma collection process without HIV testing. From the end of 1994 to the beginning of 1995, local outbreaks of the infection started occurring in certain provinces including Hebei, Anhui, and Henan. This HIV epidemic was subsequently found to have originated among plasma donors [45]. It was reported that 326 patients from whom blood was donated at plasmapheresis centers in Hebei Province were identified as HIV-positive during 1995-2013. These HIV infections were proven to have started in October 1994 [2]
Finally, the Technical Operation Procedures in Blood Stations standardized donor screening, which has become an essential testing step at blood collection centers since 1997 [46]. From then on, each unit of blood has had to be tested for blood grouping, hemoglobin, alanine aminotransferase (ALT), and HBV surface antigen (HBsAg) before collection. Donated blood (post-collection) has to undergo comprehensive donor testing twice, using different equipment and/or different personnel, including HIV, HBV, hepatitis C virus, ALT, and syphilis [47].
In the following two decades, testing was strictly implemented. Equipment and technology were updated continuously. For blood group, the RhD type has been mandatorily appraised since 2012 [48]. For serum markers, the colloidal gold strip method was used to detect HBV markers in the early 1990s. Since 1997, serum markers have been tested using an enzyme-linked immunosorbent assay (ELISA) reagent [46]. Since 2010, the Chinese government has established the NAT system in several regions, such as Beijing and Shanghai, covering all types of donations and making great progress in improving blood safety [49]. Due to huge operating costs and the shortage of qualified staff in blood centers, NATs were mainly implemented at the provincial level of blood centers in 2013 [15]. In 2014, the blood tests completed using NAT nationwide approached 4.7 million units, which accounted for 36% of annual blood donations [16]. About 129 million dollars were invested in the nationwide expansion of NAT in 2015 [50]. Eventually, NAT and chemiluminescent immunoassay (CLIA) were formally added to this procedure, according to the Technical Operation Procedures for Blood Centers (2015 Edition) [51]. In order to simplify the procedure and improve its efficiency, serum markers only need to be detected once by ELISA or CLIA except NAT since 2019 [52]. As shown in Figure 4, the window of HIV, HBV, HCV is shortened when using NAT from 50, 72, and 22 days to 25, 59, and 11 days, respectively [53].
By analyzing the litigation related to transfusion from 1981 to 2020, we found that the number of cases experienced a huge reduction, since HCV was required to be tested for in 1994 (Figure 5). Adverse reactions to blood transfusions accounted for 5.6% of all documents, HBV infections accounted for 5.3%, HIV infections accounted for 11.0%, HCV infections accounted for 76.7%, and syphilis infections accounted for 2.3%. HCV infections took the largest share, 55.8% of which occurred before 1994.
Transformation of liability in blood transfusion malpractice
Process optimization and technology updates have improved blood safety directly, but the risk of blood transfusion cannot be eliminated completely for some unpredictable factors such as infections, venous thromboembolism [54], transfusion-related lung injury, and transfusion-associated graft-versus-host disease [55]. Therefore, who undertakes this liability is crucial.
Before 1993, there were no regulations related to adverse events caused by transfusion. For instance, medical institutions or blood stations would not be held accountable for HIV infections caused by blood transfusion because the HIV antibody was not required to be tested for until 1993 [46]. Between 1993 and 2002, there were no laws or regulations to compensate for the adverse events caused by blood transfusion, leaving the issue to be addressed by civil law. The judgment results often depended on the opinions of judges and juries.
Between 2002 and 2010, according to Article 33 of the Regulation on the Handling of Medical Accidents, the fault liability principle was deemed applicable in transfusion. It was found that hospitals were not responsible for no-fault transfusion [56], meaning that the hospital does not bear legal responsibility as long as the process meets inspection standards and the technical index, despite the unfavorable consequences caused by infections resulting from blood quality. Moreover, in case of emergency, infections caused by blood transfusion were exempted on the principle that life extension was more important than long-term quality of life. Obviously, this was not fair for the patient who received HIV or HBV infections through transfusion. Thus, in judicial practice, hospitals were ordered to pay compensation patients in cases of infection regardless of whether the transfusion process was in error, for the sake of fairness [57]. Of the 301 cases, 236 hospitals or blood stations in China paid compensation for infections related to transfusion from 1981 to 2018.
After 2010, according to Article 59 of the Tort Law of China, damage from transfusion was classified as a special no-fault liability tort. It was the first time it was clearly defined that patients could claim compensation. This principle instituted the protection of the rights and interests of patients. Although the hospital may not be at fault in the whole process, they should assume tort liability for infringing upon a civil right or interest of the patient and pay compensation. As shown in Figure 5, the number of decisions reached its peak in 2015, which is significantly due to the Tort Law of China. Generally, the trial process takes three to four years after prosecution. Basically, the patient has the right to claim compensation from the blood center or the hospital if he or she suffered any adverse event due to transfusion or infected blood.